NMPA (CFDA) published Guideline for Imported Medical Device Legal Agent (Draft) for feedback on Aug 3rd, 2018. The draft guideline lists 3 responsibilities for legal agents for the first time:
- Conduct yearly self-inspection for overseas manufacturers and legal agent itself;
- Assist manufacturers meet requirements for Conditional Approval. (The Conditional Approvals will be used more often to accelerate the innovation & market acceptance. Devices and IVDs can be approved without enough clinical data, if manufacturers are committed to do further clinical research.)
- Responsible for Chinese IFU. (From January 1st, 2019, for all imported class II and III products, Chinese company name should be included in the Chinese IFU and Label, and should be consistent with that in the CFDA certificate of the product. Click HERE for more info.)
Legal agent will play a far more significant role than ever before. China Med Device, LLC is a CFDA certified legal agent. We can help you fulfill the pre and post market legal agent requirements without your needing to setup office in China. For more details on legal agent regulations, email us at info@ChinaMedDevice.com.
The other responsibilities of legal agents include:
- Handle the registration or filing of imported medical devices;
- Monitor and report the adverse events in China, and feedback to foreign manufacturers and regulatory agencies; Assist regulatory agencies with quality inspection;
- Keep track with sales and distribution and ensure that products are traceable；
- Notify foreign manufacturers of any regulatory updates and technical requirements;
- Investigate and handle consumer complaints, and report to foreign manufacturers;
- Share liability with manufacturer on quality and service issues.
NMPA (CFDA) issued Decree No.1 for Medical Device Adverse Event Reporting on August 31st, 2018. The Decree specifies that overseas adverse events are required to be reported, and the report must be conducted by legal agent in China.
The final version of Guideline for Imported Medical Device Legal Agent is scheduled to be published early next year.
For CFDA link of Guideline for Imported Medical Device Legal Agent (Draft), please email info@ChinaMedDevice.com.
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About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. Our NMPA (CFDA) regulatory services include: regulatory strategy, RA, clinical evaluation report (CER), clinical trial, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership, and distribution qualification. We are a NMPA (CFDA) certified legal agent. With offices in Boston and Beijing, we can service our clients 24/7.
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Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------